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Talk to a SpecialistTalk to a SpecialistGreen Wave Analytical, LLC, a contract testing laboratory for finished sterile injectable drugs and components, failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods as required by CGMP regulations (21 CFR 211.165(e)). The company's violations rendered the drugs it tested adulterated under federal law, and the situation was compounded by the firm's denial of FDA inspector access to its registered facility and false representations that it did not perform CGMP testing during the first three days of the February-March 2022 inspection. No corrective action response was received from the firm following the inspection observations documented on FDA Form 483.